U.S. patent application number 14/705868 was filed with the patent office on 2016-02-25 for treatment systems, small volume applicators, and methods for treating submental tissue.
This patent application is currently assigned to ZELTIQ AESTHETICS, INC.. The applicant listed for this patent is Joseph Coakley, George Frangineas, JR., Tamara Hilton, Peter Yee. Invention is credited to Joseph Coakley, George Frangineas, JR., Tamara Hilton, Peter Yee.
Application Number | 20160051401 14/705868 |
Document ID | / |
Family ID | 55347292 |
Filed Date | 2016-02-25 |
United States Patent
Application |
20160051401 |
Kind Code |
A1 |
Yee; Peter ; et al. |
February 25, 2016 |
TREATMENT SYSTEMS, SMALL VOLUME APPLICATORS, AND METHODS FOR
TREATING SUBMENTAL TISSUE
Abstract
Systems for treating a subject's tissue can include a thermally
conductive cup, a tissue-receiving cavity, and a vacuum port. The
vacuum port is in fluid communication with the tissue-receiving
cavity to provide a vacuum for drawing the submental tissue, or
other targeted tissue, into the tissue-receiving cavity. A thermal
device can cool and/or heat the conductive cup such that the
conductive cup non-invasively controls the temperature of
subcutaneous lipid-rich cells in the tissue. A restraint apparatus
can hold a the conductive cup in thermal contact with the target
region.
Inventors: |
Yee; Peter; (San Ramon,
CA) ; Coakley; Joseph; (Dublin, CA) ;
Frangineas, JR.; George; (Fremont, CA) ; Hilton;
Tamara; (Pleasanton, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Yee; Peter
Coakley; Joseph
Frangineas, JR.; George
Hilton; Tamara |
San Ramon
Dublin
Fremont
Pleasanton |
CA
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
ZELTIQ AESTHETICS, INC.
Pleasanton
CA
|
Family ID: |
55347292 |
Appl. No.: |
14/705868 |
Filed: |
May 6, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62039213 |
Aug 19, 2014 |
|
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|
Current U.S.
Class: |
607/109 |
Current CPC
Class: |
A61F 2007/0239 20130101;
A61F 2007/0071 20130101; A61F 2007/0075 20130101; A61F 2007/0056
20130101; A61F 2007/001 20130101; A61F 2007/0012 20130101; A61B
90/14 20160201; A61F 7/007 20130101 |
International
Class: |
A61F 7/00 20060101
A61F007/00 |
Claims
1. An apparatus for treating a subject's submental tissue,
comprising: a thermally conductive cup including a first sidewall,
a second sidewall, and a bottom; a tissue-receiving cavity; at
least one vacuum port in fluid communication with the
tissue-receiving cavity to provide a vacuum for drawing the
submental tissue into the tissue-receiving cavity, wherein the
tissue-receiving cavity is sufficiently shallow to allow the
subject's submental tissue to occupy substantially the entire
tissue-receiving cavity when the vacuum is drawn via the at least
one vacuum port; and a thermal device in thermal communication with
the conductive cup, wherein the thermal device is configured to
cool the conductive cup such that the first sidewall, the second
sidewall, and the bottom together non-invasively cool subcutaneous
lipid-rich cells in the submental tissue an amount sufficient to be
biologically effective in damaging and/or reducing the subcutaneous
lipid-rich cells.
2. The apparatus of claim 1 wherein each of the first sidewall, the
second sidewall, and the bottom is positioned to absorb heat from
the submental tissue to damage and/or reduce the lipid-rich cells,
which are in a subcutaneous layer of adipose tissue, in number
and/or size to an extent while non-lipid-rich cells deeper than the
subcutaneous layer of adipose tissue are not reduced in number
and/or size to the extent.
3. The apparatus of claim 1, further comprising a pressurization
device in fluid communication with the tissue-receiving cavity via
the vacuum port; and a controller with instructions for causing the
apparatus to hold the submental tissue in the tissue-receiving
cavity using suction provided by the pressurization device while
the conductive cup conductively cools the subject's tissue.
4. The apparatus of claim 1 wherein the conductive cup includes a
metal surface that faces the tissue-receiving cavity and has an
area equal to or less than about 40 cm.sup.2.
5. The apparatus of claim 1 wherein the tissue-receiving cavity has
a length between opposing end walls of the conductive cup, a width
between the first and second sidewalls, and a depth between an
opening of the tissue-receiving cavity and the bottom of the
conductive cup, wherein the depth is substantially uniform along
most of the length of the tissue-receiving cavity.
6. The apparatus of claim 1, further comprising a restraint
apparatus configured to hold a subject's head, wherein the
restraint apparatus includes an adjustable pillow including a head
cradle portion and being operable to controllably adjust tilt of
the subject's head supported by the head cradle portion; and at
least one restraint coupleable to the pillow such that the at least
one restraint holds the conductive cup in thermal contact with the
subject's submental region while the subject's head is supported by
the head cradle portion.
7. An apparatus for treating a subject's tissue, comprising: a
submental vacuum applicator including a tissue-receiving cavity, a
contoured lip defining a mouth of the tissue-receiving cavity and
including a first arcuate lip portion and a second arcuate lip
portion, wherein the contoured lip is configured to engage a
submental area of the subject such that mostly submental tissue of
the subject extends through the mouth and fills substantially all
of the tissue-receiving cavity while the submental vacuum
applicator draws a vacuum and the first and second arcuate lip
portions surround at least a portion of the subject's body, and a
thermal device positioned to be in thermal contact with the
submental tissue in the tissue-receiving cavity such that the
thermal device is operable to non-invasively cool subcutaneous
lipid-rich cells in the submental tissue an amount sufficient to be
biologically effective in damaging and/or reducing the subcutaneous
lipid-rich cells.
8. The apparatus of claim 7, further comprising a controller with
instructions for causing the thermal device to cool a conductive
cup of the submental vacuum applicator such that the submental
vacuum applicator non-invasively cools the subcutaneous lipid-rich
cells to a temperature less than about 0.degree. C.
9. The apparatus of claim 7 wherein the tissue-receiving cavity
includes a first end, a second end, and a central section extending
between the first and second ends, and wherein the central section
has a curved longitudinal axis and a substantially uniform maximum
depth along most of the curved longitudinal axis.
10. The apparatus of claim 9 wherein the curved longitudinal axis
has the same curvature as a curvature of at least one of the first
and second arcuate lip portions.
11. The apparatus of claim 7 wherein the tissue-receiving cavity
has a substantially uniform maximum depth along most of a
longitudinal length of the tissue-receiving cavity.
12. The apparatus of claim 7, further comprising a vacuum source
fluidically coupled to the tissue-receiving cavity and configured
to provide sufficient vacuum to draw the submental tissue to a
bottom of the tissue-receiving cavity to bring the submental tissue
into thermal contact with a concave metal heat-exchanging surface
of the submental vacuum applicator.
13. The apparatus of claim 7 wherein the submental vacuum
applicator includes an applicator unit and a liner assembly
removably attached to the applicator unit.
14. A method of non-invasively cooling a submental region of a
subject, the method comprising: placing a submentum applicator on
the subject, wherein the submentum applicator includes a vacuum cup
and a tissue-receiving cavity; drawing submental tissue through the
tissue-receiving cavity and into thermal contact with a section of
the vacuum cup located at a bottom of the tissue-receiving cavity;
and conductively extracting heat from the submental tissue to the
submentum applicator so as to cool the submental tissue an amount
sufficient to be biologically effective in selectively damaging
and/or reducing subcutaneous submental lipid-rich cells.
15. The method of claim 14 wherein conductively extracting heat
from the submental tissue causes damage to and/or reduction of a
sufficient amount of the submental subcutaneous lipid-rich cells to
visibly reduce a double chin of the subject.
16. The method of claim 14, further comprising supporting the
subject's head on an adjustable pillow, wherein the adjustable
pillow includes a deployable head cradle portion and is capable of
controllably adjusting the forward tilt of a subject's head
supported by the head cradle portion; and holding the submentum
applicator in thermal contact with the submental region using at
least one restraint coupled to the pillow.
17. A system for treating a subject, comprising: a restraint
apparatus configured to hold a subject's head and including an
adjustable pillow including a head cradle portion, wherein the
adjustable pillow is operable to controllably adjust tilt of the
subject's head supported by the head cradle portion; and at least
one restraint coupleable to the adjustable pillow such that the at
least one restraint holds a tissue-cooling apparatus in thermal
contact with the subject's submental region while the subject's
head is supported at a desired angle by the head cradle portion
18. The system of claim 17, further comprising the tissue-cooling
apparatus, wherein the at least one restraint and the adjustable
pillow are configured to cooperate to inhibit movement of the
tissue-cooling apparatus relative to the subject's submental region
while the tissue-cooling apparatus non-invasively cools
subcutaneous lipid-rich cells at the subject's submental region an
amount sufficient to be biologically effective in damaging and/or
reducing the subcutaneous lipid-rich cells.
19. The system of claim 17 wherein the restraint apparatus further
comprises a head adjuster device operable to reconfigure the head
cradle portion to achieve the desired tilt of the subject's head;
and a neck adjuster device independently operable to reconfigure a
neck support portion of the adjustable pillow to achieve desired
neck tilt of the subject.
20. The system of claim 17 wherein the restraint apparatus further
includes a cradle adjuster device with a first expandable element
that expands a sufficient amount to tilt the head cradle portion
and increase forward tilt of the subject's head; and a neck
adjuster device with a second expandable element that independently
expands so as to cause a neck support portion of the pillow to push
against a posterior region of the subject's neck.
21. The system of claim 17 wherein the adjustable pillow includes a
shoulder support portion and a neck support portion positioned
between the shoulder support portion and the head cradle portion,
wherein the neck support portion is movable relative to the
shoulder support portion and the head cradle portion such that the
neck support portion pushes against the posterior region of the
subject's neck.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit under 35 U.S.C.
.sctn.119(e) of U.S. Provisional Patent Application No. 62/039,213
filed Aug. 19, 2014, which is incorporated by reference in its
entirety.
INCORPORATION BY REFERENCE OF COMMONLY-OWNED APPLICATIONS AND
PATENTS
[0002] The following commonly assigned U.S. patent applications and
U.S. patents are incorporated herein by reference in their
entireties:
[0003] U.S. Patent Publication No. 2008/0287839 entitled "METHOD OF
ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS AND
TREATMENT APPARATUS HAVING AN ACTUATOR";
[0004] U.S. Pat. No. 6,032,675 entitled "FREEZING METHOD FOR
CONTROLLED REMOVAL OF FATTY TISSUE BY LIPOSUCTION";
[0005] U.S. Patent Publication No. 2007/0255362 entitled
"CRYOPROTECTANT FOR USE WITH A TREATMENT DEVICE FOR IMPROVED
COOLING OF SUBCUTANEOUS LIPID-RICH CELLS";
[0006] U.S. Pat. No. 7,854,754 entitled "COOLING DEVICE FOR
REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
[0007] U.S. Patent Publication No. 2011/0066216 entitled "COOLING
DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
[0008] U.S. Patent Publication No. 2008/0077201 entitled "COOLING
DEVICES WITH FLEXIBLE SENSORS";
[0009] U.S. Patent Publication No. 2008/0077211 entitled "COOLING
DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO
PROVIDE A PREDETERMINED COOLING PROFILE";
[0010] U.S. Patent Publication No. 2009/0118722, filed Oct. 31,
2007, entitled "METHOD AND APPARATUS FOR COOLING SUBCUTANEOUS
LIPID-RICH CELLS OR TISSUE";
[0011] U.S. Patent Publication No. 2009/0018624 entitled "LIMITING
USE OF DISPOSABLE SYSTEM PATIENT PROTECTION DEVICES";
[0012] U.S. Patent Publication No. 2009/0018623 entitled "SYSTEM
FOR TREATING LIPID-RICH REGIONS";
[0013] U.S. Patent Publication No. 2009/0018625 entitled "MANAGING
SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICH REGIONS";
[0014] U.S. Patent Publication No. 2009/0018627 entitled "SECURE
SYSTEM FOR REMOVING HEAT FROM LIPID-RICH REGIONS";
[0015] U.S. Patent Publication No. 2009/0018626 entitled "USER
INTERFACES FOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH
REGIONS";
[0016] U.S. Pat. No. 6,041,787 entitled "USE OF CRYOPROTECTIVE
AGENT COMPOUNDS DURING CRYOSURGERY";
[0017] U.S. Pat. No. 8,285,390 entitled "MONITORING THE COOLING OF
SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE
TISSUE";
[0018] U.S. Pat. No. 8,275,442 entitled "TREATMENT PLANNING SYSTEMS
AND METHODS FOR BODY CONTOURING APPLICATIONS";
[0019] U.S. patent application Ser. No. 12/275,002 entitled
"APPARATUS WITH HYDROPHILIC RESERVOIRS FOR COOLING SUBCUTANEOUS
LIPID-RICH CELLS";
[0020] U.S. patent application Ser. No. 12/275,014 entitled
"APPARATUS WITH HYDROPHOBIC FILTERS FOR REMOVING HEAT FROM
SUBCUTANEOUS LIPID-RICH CELLS";
[0021] U.S. Patent Publication No. 2010/0152824 entitled "SYSTEMS
AND METHODS WITH INTERRUPT/RESUME CAPABILITIES FOR COOLING
SUBCUTANEOUS LIPID-RICH CELLS";
[0022] U.S. Pat. No. 8,192,474 entitled "TISSUE TREATMENT
METHODS";
[0023] U.S. Patent Publication No. 2010/0280582 entitled "DEVICE,
SYSTEM AND METHOD FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH
CELLS";
[0024] U.S. Patent Publication No. 2012/0022518 entitled "COMBINED
MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR BODY
CONTOURING APPLICATIONS";
[0025] U.S. Publication No. 2011/0238050 entitled "HOME-USE
APPLICATORS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS
LIPID-RICH CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED DEVICES,
SYSTEMS AND METHODS";
[0026] U.S. Publication No. 2011/0238051 entitled "HOME-USE
APPLICATORS FOR NON-INVASIVELY REMOVING HEAT FROM SUBCUTANEOUS
LIPID-RICH CELLS VIA PHASE CHANGE COOLANTS, AND ASSOCIATED DEVICES,
SYSTEMS AND METHODS";
[0027] U.S. Publication No. 2012/0239123 entitled "DEVICES,
APPLICATION SYSTEMS AND METHODS WITH LOCALIZED HEAT FLUX ZONES FOR
REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS";
[0028] U.S. patent application Ser. No. 13/830,413 entitled
"MULTI-MODALITY TREATMENT SYSTEMS, METHODS AND APPARATUS FOR
ALTERING SUBCUTANEOUS LIPID-RICH TISSUE";
[0029] U.S. patent application Ser. No. 13/830,027 entitled
"TREATMENT SYSTEMS WITH FLUID MIXING SYSTEMS AND FLUID-COOLED
APPLICATORS AND METHODS OF USING THE SAME";
[0030] U.S. patent application Ser. No. 11/528,225 entitled
"COOLING DEVICE HAVING A PLURALITY OF CONTROLLABLE COOLING ELEMENTS
TO PROVIDE A PREDETERMINED COOLING PROFILE;" and
[0031] U.S. Pat. No. 8,285,390 entitled "MONITORING THE COOLING OF
SUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE
TISSUE."
TECHNICAL FIELD
[0032] The present disclosure relates generally to treatment
systems for cooling and/or cooling targeted regions. Several
embodiments are directed to treatment systems with non-invasive
applicators that hold and cool/heat relatively small volumes of
tissue. Several embodiments can also include restraint apparatuses
for holding non-invasive applicators in thermal contact with
patients.
BACKGROUND
[0033] Excess body fat, or adipose tissue, may be present at
various locations of a subject's body and may detract from personal
appearance. Excess subcutaneous fat under the chin and/or around
the neck can be cosmetically unappealing and, in some instances,
can produce a "double chin." A double chin can cause stretching
and/or sagging of skin and may also result in discomfort. Excess
adipose tissue in superficial fat compartments can produce loose
facial structures, such as loose jowls, that also cause an
undesirable appearance. Excess body fat can also be located at the
abdomen, thighs, buttocks, knees, and arms, as well as other
locations.
[0034] Aesthetic improvement of the human body often involves the
selective removal of adipose tissue. Invasive procedures (e.g.,
liposuction), however, tend to be associated with relative high
costs, long recovery times, and increased risk of complications.
Injection of drugs for reducing adipose tissue, such as submental
or facial adipose tissue, can cause significant swelling, bruising,
pain, numbness, and/or induration. Conventional non-invasive
treatments for reducing adipose tissue often include regular
exercise, application of topical agents, use of weight-loss drugs,
dieting, or a combination of these treatments. One drawback of
these non-invasive treatments is that they may not be effective or
even possible under certain circumstances. For example, when a
person is physically injured or ill, regular exercise may not be an
option. Topical agents and orally administered weight-loss drugs
are not an option if, as another example, they cause an undesirable
reaction (e.g., an allergic or negative reaction). Additionally,
non-invasive treatments may be ineffective for selectively reducing
specific regions of adiposity. For example, localized fat loss
around the neck, jaw, cheeks, etc. often cannot be achieved using
general or systemic weight-loss methods. Accordingly, conventional
invasive and non-invasive treatments are not suitable for many
subjects and cannot effectively target certain regions of adipose
tissue.
SUMMARY OF TECHNOLOGY
[0035] Systems for treating a subject's tissue can include a
thermally conductive cup, a tissue-receiving cavity, and a vacuum
port. The vacuum port can be in fluid communication with the
tissue-receiving cavity to provide a vacuum for drawing the
submental tissue, or other targeted tissue, into the
tissue-receiving cavity. The system can cool and/or heat the
conductive cup such that the conductive cup non-invasively controls
the temperature of subcutaneous lipid-rich cells in the tissue. A
restraint apparatus can hold the thermally conductive cup in
thermal contact with a patient's tissue.
[0036] At least some embodiments are apparatuses for treating a
subject's submental tissue and can include a thermally conductive
cup, at least one vacuum port, and a thermal device. The thermally
conductive cup can include a first sidewall, a second sidewall, and
a bottom. The vacuum port can be in fluid communication with a
tissue-receiving cavity of the cup to provide a vacuum for drawing
the submental tissue into the tissue-receiving cavity. The
tissue-receiving cavity can be sufficiently shallow to allow the
subject's submental tissue to occupy substantially the entire
tissue-receiving cavity when the vacuum is drawn via the vacuum
port. The thermal device can be in thermal communication with the
conductive cup. The thermal device can be configured to cool the
conductive cup such that the first sidewall, second sidewall, and
bottom together non-invasively cool subcutaneous lipid-rich cells
in the submental tissue. For example, the subcutaneous lipid-rich
cells can be cooled an amount sufficient to be biologically
effective in damaging and/or reducing the subcutaneous lipid-rich
cells or other targeted cells.
[0037] The first sidewall, second sidewall, and bottom can be
positioned to absorb heat from the submental tissue to damage
and/or reduce the lipid-rich cells, which are in a subcutaneous
layer of adipose tissue, in number and/or size to an extent while
non-lipid-rich cells deeper than the subcutaneous layer of adipose
tissue are not reduced in number and/or size to the extent. In some
embodiments, the apparatus can include a pressurization device in
fluid communication with the tissue-receiving cavity via the vacuum
port. A controller can include instructions for causing the
apparatus to hold the submental tissue in the tissue-receiving
cavity using suction provided by the pressurization device.
[0038] The conductive cup can be in thermal contact with most of
the subject's skin at the subject's submental region when the
tissue-receiving cavity is partially or completely filled with the
subject's tissue. The conductive cup can include a conductive
surface (e.g., metal surface) that faces the tissue-receiving
cavity and has an area equal to or less than about, for example, 40
cm.sup.2. In some embodiments, the conductive cup can include a
smooth thermally conductive surface that extends continuously along
the first sidewall, second sidewall, and bottom.
[0039] The tissue-receiving cavity can be dimensioned to receive
most of the subject's skin located at the submental region of the
subject. In some embodiments, the tissue-receiving cavity has a
length between opposing end walls of the conductive cup, a width
between the first and second sidewalls, and a depth between an
opening of the tissue-receiving cavity and the bottom of the
conductive cup. The depth is substantially uniform along most of
the length of the tissue-receiving cavity.
[0040] A liner assembly can line the conductive cup such that the
liner assembly is positioned between the subject's tissue in the
tissue-receiving cavity and the conductive cup. The linear assembly
can be made of plastic, rubber, or other suitable material and can
carry and/or include one or more sensors.
[0041] In some embodiments, an apparatus for treating a subject's
tissue includes a submental vacuum applicator. The submental vacuum
applicator can include a tissue-receiving cavity, a contoured lip,
and a thermal device. The contoured lip can define a mouth of the
tissue-receiving cavity and can include first and second arcuate
lip portions. The contoured lip can be configured to engage a
submental area of the subject such that mostly submental tissue
extends through the mouth and fills substantially all of the
tissue-receiving cavity while the submental vacuum applicator draws
a vacuum and the first and second arcuate lip portions surround at
least a portion of the subject's body. The thermal device can be
positioned to be in thermal contact with the submental tissue in
the tissue-receiving cavity. The thermal device is operable to
non-invasively cool subcutaneous lipid-rich cells in the submental
tissue an amount sufficient to be biologically effective in
damaging, reducing, and/or otherwise affecting the subcutaneous
lipid-rich cells.
[0042] The apparatus can include a controller with instructions for
causing the submental vacuum applicator to cool a conductive cup
such that the submental vacuum applicator non-invasively cools the
subcutaneous lipid-rich cells to a temperature less than about
predetermined temperature (e.g., about 0.degree. C., about
-1.8.degree. C., etc.). The controller can include one or more
processors, memory, power supplies, or other electrical
components.
[0043] The tissue-receiving cavity can include a first end, a
second end, and a central section extending between the first and
second ends. The central section has a curved longitudinal axis and
a substantially uniform maximum depth along most of the curved
longitudinal axis. In one embodiment, the curved longitudinal axis
has the same curvature as a curvature of at least one of the first
and second arcuate lip portions. In one embodiment, the
tissue-receiving cavity has a substantially uniform maximum depth
along most of a longitudinal length of the tissue-receiving
cavity.
[0044] The apparatus can further include a vacuum source
fluidically coupled to the tissue-receiving cavity. The vacuum
source can be configured to provide sufficient vacuum to draw the
submental tissue toward a bottom of the tissue-receiving cavity to
bring the submental tissue into thermal contact with a concave
metal heat-exchanging surface of the submental vacuum
applicator.
[0045] The submental vacuum applicator, in some embodiments, can
include an applicator unit and a liner assembly removably attached
to the applicator unit. In other embodiments, the applicator unit
can be used without any liner assembly.
[0046] In further embodiments, a method of non-invasively cooling a
submental region of a subject includes placing a submentum
applicator on the subject. The submentum applicator includes a
vacuum cup and a tissue-receiving cavity. Submental tissue can be
drawn through the tissue-receiving cavity and into thermal contact
with a section of the vacuum cup located at a bottom of the
tissue-receiving cavity. Heat can be conductively extracted from
the submental tissue by the submentum applicator so as to cool the
submental tissue an amount sufficient to be biologically effective
in selectively damaging and/or reducing subcutaneous submental
lipid-rich cells. Heat can be repeatedly extracted from the
subcutaneous submental tissue until desired tissue reduction is
achieved. In some embodiments, a sufficient amount of heat can be
conductively extracted from the submental tissue to visibly reduce
a double chin of the subject.
[0047] The conductive extraction of heat can include conductively
cooling an area of the subject's submental skin that is equal to or
less than about 40 cm.sup.2. In some embodiments, a concave
heat-exchanging surface of the applicator can be cooled to a
temperature equal to or less than a selected temperature (e.g.,
0.degree. C.). In some embodiments, most of a heat-exchanging
surface of a conductive cup of the vacuum applicator can be cooled
to a temperature equal to or less than about -5.degree. C. The
submental tissue can be pulled into the tissue-receiving cavity
such that the tissue-receiving cavity is filled mostly with
submental tissue. In some embodiments, a vacuum can be drawn to
pull the submental tissue into the tissue-receiving cavity and can
result in a relatively large contact area for heat transfer with
the target tissue.
[0048] In some embodiments, a system includes a restraint apparatus
configured to hold a subject's head. The restraint apparatus can
include an adjustable pillow and restraints. The pillow can include
a head cradle portion operable to controllably adjust tilt of a
subject's head. The restraints are coupleable to the pillow such
that the restraints hold a tissue-cooling apparatus in thermal
contact with the subject's submental region while the subject's
head is supported at a desired tilt by the head cradle portion.
[0049] The system can further include a tissue-cooling apparatus
configured to be connected to the pillow by the restraints. The
restraints and pillow cooperate to inhibit movement of the
tissue-cooling apparatus relative to the subject's submental region
while the tissue-cooling apparatus non-invasively cools
subcutaneous lipid-rich cells at the subject's submental region.
For example, the subcutaneous lipid-rich cells can be cooled an
amount sufficient to be biologically effective in damaging and/or
reducing the subcutaneous lipid-rich cells. In some embodiments,
the pillow and restraints can be configured to cooperate to inhibit
movement of the subject's head while the tissue-cooling apparatus
transcutaneously cools the subject's submental region.
[0050] The restraint apparatus, in some embodiments, further
includes a head adjuster device and a neck adjuster device for
reconfiguring the pillow. The head adjuster device is operable to
reconfigure the head cradle portion of the pillow to achieve the
desired tilt of the subject's head. The neck adjuster device is
operable to reconfigure a neck support portion of the pillow to
achieve desired neck tilt. In one embodiment, the head adjuster
device has a bladder that expands to increase a slope of a tilted
support surface of the head cradle portion so as to tilt the
subject's head forward. In another embodiment, the head adjuster
device includes a bladder located within an expandable opening of
the pillow. The bladder can be inflated to expand at least a
portion of the pillow to adjust head tilt of the subject.
[0051] The pillow, in some embodiments, can include a neck support
portion which is positioned to be located under the subject's neck
when the subject's head is supported by the head cradle portion. A
neck adjuster device is operable to move the neck support portion
against the subject's neck to adjust neck tilt of the subject. In
some embodiments, the pillow includes side portions positionable on
opposite sides of the subject's head. The restraint apparatus can
be configured to extend across at least a portion of the subject's
body to hold the tissue-cooling apparatus in thermal contact with
the subject's submental region. The pillow can include a shoulder
support portion and a neck support portion positioned between the
shoulder support portion and the head cradle portion. The neck
support portion can be moved relative to the shoulder support
portion and/or head cradle portion to push against the posterior
region of the subject's neck.
[0052] The restraint apparatus, in some embodiments, can include a
cradle adjuster device and a neck adjuster device. The cradle
adjuster device can have a first expandable element that can expand
a sufficient amount to increase forward tilt of the subject's head.
The neck adjuster device can have a second expandable element that
can expand so as to cause the neck support portion to push against
the subject's neck (e.g., a posterior region of the subject's neck)
when the posterior region of the subject's head rests on the head
cradle portion. The first and second expandable elements can be
independently expanded to independently move different regions of
the pillow.
[0053] In some embodiments, a system configured to position a
subject's body includes an adjustable pillow configured to support
the subject's head. The pillow can include a head cradle, a head
adjuster device, and a neck adjuster device. The head cradle has
side portions positioned to contact opposite sides of a subject's
head received by the head cradle to inhibit movement of the
subject's head. The head adjuster device is operable to tilt the
head cradle portion to achieve desired tilt of the subject's head.
The neck adjuster device is operable to reconfigure a neck support
portion of the pillow such that the neck support portion pushes
against the subject's neck to achieve desired neck tilt.
[0054] The system can further include one or more restraints
configured to hold a tissue-cooling apparatus in thermal contact
with the subject's submental region while the head cradle inhibits
movement of the subject's head relative to the tissue-cooling
apparatus. In one embodiment, the restraints have an open
configuration for allowing the subject's head to be moved into or
out of the head cradle and a closed configuration for keeping the
subject's head in the head cradle. In some embodiments, the
restraints can be tensioned to pull the tissue-cooling apparatus
toward the subject's submental region. The restraint apparatus can
include hook and loop fastener that detachably couples the
restraints to the pillow. For example, the loop fastener can be
part of or attached to the pillow. The hook fastener can be part of
or attached to the restraints. In other embodiments, the system can
include a harness, straps, fasteners (e.g., buckles, snaps, etc.),
and/or other coupling means for holding the subject's body,
tissue-cooling apparatus, or the like.
[0055] The system, in some embodiments, further includes a
tissue-cooling apparatus and at least one restraint. The
tissue-cooling apparatus is configured to non-invasively cool
subcutaneous lipid-rich cells at the subject's submental region an
amount sufficient to be biologically effective in damaging and/or
reducing the subcutaneous lipid-rich cells. The restraint is
detachably coupleable to the pillow and detachably coupleable to
the tissue-cooling apparatus. The tissue-cooling apparatus can be a
handheld device with one or more thermoelectric cooling devices
(e.g., Peltier devices), cooling channels, sensors, electrical
components (e.g., circuitry, controllers, etc.), and/or other
components.
[0056] At least some treatment systems disclosed herein can include
a restraint apparatus that includes an adjustable pillow and means
for stabilizing a tissue-cooling apparatus. In some embodiments,
the means for stabilizing the tissue-cooling apparatus can include
one or more restraints. The pillow can include a head cradle
portion and means for controllably adjusting tilt of the subject's
head and/or neck supported by the adjustable pillow. In one
embodiment, the means for controllably adjusting tilt of the
subject's head and/or neck includes a bladder insertable into the
adjustable pillow and a pump connected to the bladder. In one
embodiment, the means for controllably adjusting tilt of the
subject's head and/or neck includes a cradle adjuster device and a
neck adjuster device. The cradle adjuster device is positionable in
the head cradle portion and can be expanded to increase forward
tilt of the subject's head. The neck adjuster device can be
expanded to cause a neck support portion of the pillow to push
against the subject's neck when the subject's head is supported by
the head cradle portion.
[0057] The head cradle portion, in some embodiments, can include
side portions spaced apart to be positioned on opposite sides of
the subject's head. The means for stabilizing the tissue-cooling
apparatus can include restraints connectable to the side portions
such that the one or more of the restraints extend across the
subject's body to hold the tissue-cooling apparatus in thermal
contact with the subject's submental region. In some embodiments,
the means for stabilizing the tissue-cooling apparatus includes a
retention system with one or more restraints, straps, or other
coupling features.
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] In the drawings, identical reference numbers identify
similar elements or acts.
[0059] FIG. 1 is a partially schematic, isometric view of a
treatment system for non-invasively affecting target regions of a
subject in accordance with an embodiment of the technology.
[0060] FIG. 2 is a cross-sectional view of a connector taken along
line 2-2 of FIG. 1.
[0061] FIG. 3 is a side view of an applicator applied to a subject
while the subject's head is supported by an adjustable pillow in
accordance with embodiments of the technology.
[0062] FIG. 4 is a cross-sectional view of the applicator and the
subject's tissue taken along line 4-4 of FIG. 3.
[0063] FIG. 5 is an isometric view of an applicator unit suitable
for use with the system of FIG. 1 in accordance with embodiments of
the technology.
[0064] FIG. 6 is an exploded isometric view of the applicator unit
of FIG. 5.
[0065] FIG. 7 is a top view of the applicator unit of FIG. 5 in
accordance with embodiments of the technology.
[0066] FIG. 8 is a cross-sectional view of the applicator unit
taken along line 8-8 of FIG. 7.
[0067] FIG. 9 is a cross-sectional view of the applicator unit
taken along line 9-9 of FIG. 7.
[0068] FIGS. 9A and 9B are cross-sectional views of vacuum cups in
accordance with embodiments of the technology.
[0069] FIG. 10 is an isometric view of a liner assembly in
accordance with embodiments of the technology.
[0070] FIG. 11 is a top view of the liner assembly of FIG. 10.
[0071] FIG. 12 is a cross-sectional view of the liner assembly
taken along line 12-12 of FIG. 11.
[0072] FIG. 13 shows an applicator ready to be placed against a
subject's skin in accordance with embodiments of the
technology.
[0073] FIG. 14 shows the applicator contacting the subject's
skin.
[0074] FIG. 15 is a cross-sectional view of the applicator before
tissue has been drawn into a tissue-receiving cavity of the
applicator.
[0075] FIG. 16 is a cross-sectional view of the applicator after
tissue has been drawn into the tissue-receiving cavity.
[0076] FIG. 17 shows the subject after cryotherapy has been
performed.
[0077] FIGS. 18-21 are isometric views of vacuum cups in accordance
with embodiments of the present technology.
[0078] FIG. 22 is an isometric view of an applicator unit in
accordance with embodiments of the technology.
[0079] FIG. 23A is an isometric view of an applicator in accordance
with embodiments of the technology.
[0080] FIG. 23B is a side view of the applicator and connector of
FIG. 23A.
[0081] FIG. 23C is an exploded isometric view of the applicator and
connector of FIG. 23A in accordance with embodiments of the
technology.
[0082] FIG. 23D is a cross-section view of the applicator of FIG.
23A.
[0083] FIG. 24 is an isometric view of a head support assembly in
accordance with embodiments of the present technology.
[0084] FIG. 25 is a cross-sectional view of the head support
assembly taken along line 25-25 of FIG. 27 when a pillow is in an
unexpanded lowered configuration.
[0085] FIG. 26 is a cross-sectional view of the head support
assembly taken along line 26-26 of FIG. 27 when the pillow is in an
expanded raised configuration.
[0086] FIG. 27 is a top view of a pillow in accordance with
embodiments of the present technology.
[0087] FIG. 28 is a front view of the pillow of FIG. 27.
[0088] FIG. 29 is a side view of the pillow of FIG. 27.
[0089] FIGS. 30 and 31 are top views of adjuster devices in
accordance with embodiments of the present technology.
[0090] FIG. 32 is a top view of an adjustable pillow supporting the
subject's head and restraints ready to be coupled to the
pillow.
[0091] FIG. 33 is a top view of the restraint apparatus holding the
applicator in thermal contact with the subject.
[0092] FIG. 34 is a side view of the restraint apparatus holding
the applicator in thermal contact with the subject.
[0093] FIG. 35 is a schematic block diagram illustrating
subcomponents of a controller in accordance with embodiments of the
technology.
DETAILED DESCRIPTION
A. Overview
[0094] The present disclosure describes treatment systems,
applicators, and methods for affecting targeted sites. Several
embodiments are directed to non-invasive systems that cool/heat
relatively small regions or volumes of tissue, including submental
tissue, neck tissue, etc. The systems can help position the
patient's body to enhance treatment. Several of the details set
forth below are provided to describe the following examples and
methods in a manner sufficient to enable a person skilled in the
relevant art to practice, make, and use them. Several of the
details and advantages described below, however, may not be
necessary to practice certain examples and methods of the
technology. Additionally, the technology may include other examples
and methods that are within the scope of the technology but are not
described in detail.
[0095] At least some embodiments are systems for treating a
subject's tissue and can include a thermally conductive cup, a
tissue-receiving cavity, and a vacuum port. The vacuum port is in
fluid communication with the tissue-receiving cavity to provide a
vacuum for drawing the submental tissue into the tissue-receiving
cavity. The thermal device can cool or heat the conductive cup such
that the conductive cup non-invasively cools subcutaneous
lipid-rich cells in the submental tissue an amount sufficient to
affect targeted tissue. A restraint system can hold the conductive
cup at the treatment site to enhance treatment.
[0096] In some embodiments, an apparatus for treating a subject's
tissue includes a thermally conductive element, a vacuum port, and
a thermal device for heating/cooling the conductive element. The
conductive element can be a metal cup with sidewalls and a bottom.
The vacuum port can be in fluid communication with a
tissue-receiving cavity defined by the metal cup to provide a
vacuum for drawing tissue into the tissue-receiving cavity. When
the thermal device heats or cools the conductive cup, the
heated/cooled sidewalls and/or bottom can non-invasively heat/cool
subcutaneous lipid-rich cells in the submental tissue, which is
located in the tissue-receiving cavity, an amount sufficient to be
biologically effective in altering the subcutaneous lipid-rich
cells. The thermal device can include one or more cooling/heating
elements (e.g., resistive heaters, fluid-cooled elements, Peltier
devices, etc.), controllers, sensors, or combinations thereof.
[0097] The term "treatment system", as used generally herein,
refers to cosmetic or medical treatment systems, as well as any
treatment regimens or medical device usage. Several embodiments of
treatment system disclosed herein can reduce or eliminate excess
adipose tissue or other undesirable tissue treatable using
cryotherapy. The treatment systems can be used at various
locations, including, for example, a subject's face, neck, abdomen,
thighs, buttocks, knees, back, arms, ankles, and other areas. For
example, a submental region can be treated to visibly reduce or
eliminate a double chin or other unwanted tissue.
[0098] Some of the embodiments disclosed herein can be for
cosmetically beneficial alterations of target regions. Some
cosmetic procedures may be for the sole purpose of altering the
target region to conform to a cosmetically desirable look, feel,
size, shape and/or other desirable cosmetic characteristic or
feature. Accordingly, at least some embodiments of the cosmetic
procedures can be performed without providing an appreciable
therapeutic effect (e.g., no therapeutic effect). For example, some
cosmetic procedures may not include restoration of health, physical
integrity, or the physical well-being of a subject. The cosmetic
methods can target subcutaneous regions to change a subject's
appearance and can include, for example, procedures performed on
subject's submental region, face, neck, ankle region, or the like.
In other embodiments, however, cosmetically desirable treatments
may have therapeutic outcomes (whether intended or not), such as
psychological benefits, alteration of body hormones levels (by the
reduction of adipose tissue), etc.
[0099] Reference throughout this specification to "one example,"
"an example," "one embodiment," or "an embodiment" means that a
particular feature, structure, or characteristic described in
connection with the example is included in at least one example of
the present technology. Thus, the occurrences of the phrases "in
one example," "in an example," "one embodiment," or "an embodiment"
in various places throughout this specification are not necessarily
all referring to the same example. Furthermore, the particular
features, structures, routines, stages, or characteristics may be
combined in any suitable manner in one or more examples of the
technology. The headings provided herein are for convenience only
and are not intended to limit or interpret the scope or meaning of
the technology.
B. Cryotherapy
[0100] FIG. 1 and the following discussion provide a brief, general
description of a treatment system 100 in accordance with some
embodiments of the technology. The treatment system 100 can be a
temperature-controlled system for exchanging heat with a subject
101 and can include a non-invasive tissue-cooling apparatus in the
form of an applicator 102 ("applicator 102") configured to
selectively cool/heat tissue to reduce and/or eliminate targeted
tissue to achieve a desired overall appearance. The illustrated
treatment system 100 includes a restraint apparatus 107 configured
to hold the applicator 102 generally under the subject's chin to
reduce or eliminate submental lipid-rich fat cells so as to reduce
or eliminate, for example, a double chin. Skin, muscle, connective
tissue of the neck and/or face, or other non-targeted tissue can be
generally unaffected. The applicator 102 can also treat relatively
small volumes of tissue at other locations.
[0101] The treatment system 100 can perform medical treatments to
provide therapeutic effects and/or cosmetic procedures for
cosmetically beneficial effect. Without being bound by theory, the
selective effect of cooling is believed to result in, for example,
membrane disruption, cell shrinkage, disabling, disrupting,
damaging, destroying, removing, killing and/or other methods of
lipid-rich cell alteration. Such alteration is believed to stem
from one or more mechanisms acting alone or in combination. It is
thought that such mechanism(s) trigger an apoptotic cascade, which
is believed to be the dominant form of lipid-rich cell death by
non-invasive cooling. In any of these embodiments, the effect of
tissue cooling can be the selectively reduction of lipid-rich cells
by a desired mechanism of action, such as apoptosis, lipolysis, or
the like. In some procedures, the applicator 102 can cool the
tissue of the subject 101 to a temperature in a range of from about
-25.degree. C. to about 20.degree. C. In other embodiments, the
cooling temperatures can be from about -20.degree. C. to about
10.degree. C., from about -18.degree. C. to about 5.degree. C.,
from about -15.degree. C. to about 5.degree. C., or from about
-15.degree. C. to about 0.degree. C. In further embodiments, the
cooling temperatures can be equal to or less than -5.degree. C.,
-10.degree. C., -15.degree. C., or in yet another embodiment, from
about -15.degree. C. to about -25.degree. C. Other cooling
temperatures and temperature ranges can be used.
[0102] Apoptosis, also referred to as "programmed cell death", is a
genetically-induced death mechanism by which cells self-destruct
without incurring damage to surrounding tissues. An ordered series
of biochemical events induce cells to morphologically change. These
changes include cellular blebbing, loss of cell membrane asymmetry
and attachment, cell shrinkage, chromatin condensation and
chromosomal DNA fragmentation. Injury via an external stimulus,
such as cold exposure, is one mechanism that can induce cellular
apoptosis in cells. Nagle, W. A., Soloff, B. L., Moss, A. J. Jr.,
Henle, K. J. "Cultured Chinese Hamster Cells Undergo Apoptosis
After Exposure to Cold but Nonfreezing Temperatures" Cryobiology
27, 439-451 (1990).
[0103] One aspect of apoptosis, in contrast to cellular necrosis (a
traumatic form of cell death causing local inflammation), is that
apoptotic cells express and display phagocytic markers on the
surface of the cell membrane, thus marking the cells for
phagocytosis by macrophages. As a result, phagocytes can engulf and
remove the dying cells (e.g., the lipid-rich cells) without
eliciting an immune response. Temperatures that elicit these
apoptotic events in lipid-rich cells may contribute to long-lasting
and/or permanent reduction and reshaping of subcutaneous adipose
tissue.
[0104] One mechanism of apoptotic lipid-rich cell death by cooling
is believed to involve localized crystallization of lipids within
the adipocytes at temperatures that do not induce crystallization
in non-lipid-rich cells. The crystallized lipids selectively may
injure these cells, inducing apoptosis (and may also induce
necrotic death if the crystallized lipids damage or rupture the
bi-lipid membrane of the adipocyte). Another mechanism of injury
involves the lipid phase transition of those lipids within the
cell's bi-lipid membrane, which results in membrane disruption or
dysfunction, thereby inducing apoptosis. This mechanism is
well-documented for many cell types and may be active when
adipocytes, or lipid-rich cells, are cooled. Mazur, P.,
"Cryobiology: the Freezing of Biological Systems" Science, 68:
939-949 (1970); Quinn, P. J., "A Lipid Phase Separation Model of
Low Temperature Damage to Biological Membranes" Cryobiology, 22:
128-147 (1985); Rubinsky, B., "Principles of Low Temperature
Preservation" Heart Failure Reviews, 8, 277-284 (2003). Other
possible mechanisms of adipocyte damage, described in U.S. Pat. No.
8,192,474, relate to ischemia/reperfusion injury that may occur
under certain conditions when such cells are cooled as described
herein. For instance, during treatment by cooling as described
herein, the targeted adipose tissue may experience a restriction in
blood supply and thus be starved of oxygen due to isolation as a
result of applied pressure, cooling which may affect
vasoconstriction in the cooled tissue, or the like. In addition to
the ischemic damage caused by oxygen starvation and the buildup of
metabolic waste products in the tissue during the period of
restricted blood flow, restoration of blood flow after cooling
treatment may additionally produce reperfusion injury to the
adipocytes due to inflammation and oxidative damage that is known
to occur when oxygenated blood is restored to tissue that has
undergone a period of ischemia. This type of injury may be
accelerated by exposing the adipocytes to an energy source (via,
e.g., thermal, electrical, chemical, mechanical, acoustic, or other
means) or otherwise increasing the blood flow rate in connection
with or after cooling treatment as described herein. Increasing
vasoconstriction in such adipose tissue by, e.g., various
mechanical means (e.g., application of pressure or massage),
chemical means or certain cooling conditions, as well as the local
introduction of oxygen radical-forming compounds to stimulate
inflammation and/or leukocyte activity in adipose tissue may also
contribute to accelerating injury to such cells. Other yet-to-be
understood mechanisms of injury may exist.
[0105] In addition to the apoptotic mechanisms involved in
lipid-rich cell death, local cold exposure is also believed to
induce lipolysis (i.e., fat metabolism) of lipid-rich cells and has
been shown to enhance existing lipolysis which serves to further
increase the reduction in subcutaneous lipid-rich cells. Vallerand,
A. L., Zamecnik. J., Jones, P. J. H., Jacobs, I. "Cold Stress
Increases Lipolysis, FFA Ra and TG/FFA Cycling in Humans" Aviation,
Space and Environmental Medicine 70, 42-50 (1999).
[0106] One expected advantage of the foregoing techniques is that
the subcutaneous lipid-rich cells in the target region can be
reduced generally without collateral damage to non-lipid-rich cells
in the same region. In general, lipid-rich cells can be affected at
low temperatures that do not affect non-lipid-rich cells. As a
result, lipid-rich cells, such as those associated with highly
localized adiposity (e.g., submental adiposity, submandibular
adiposity, facial adiposity, etc.), can be affected while
non-lipid-rich cells (e.g., myocytes) in the same generally region
are not damaged. The unaffected non-lipid-rich cells can be located
underneath lipid-rich cells (e.g., cells deeper than a subcutaneous
layer of fat), in the dermis, in the epidermis, and/or at other
locations.
[0107] In some procedures, the treatment system 100 can remove heat
from underlying tissue through the upper layers of tissue and
create a thermal gradient with the coldest temperatures near the
cooling surface, or surfaces, of the applicator 102 (i.e., the
temperature of the upper layer(s) of the skin can be lower than
that of the targeted underlying target cells). It may be
challenging to reduce the temperature of the targeted cells low
enough to be destructive to these target cells (e.g., induce
apoptosis, cell death, etc.) while also maintaining the temperature
of the upper and surface skin cells high enough so as to be
protective (e.g., non-destructive). The temperature difference
between these two thresholds can be small (e.g., approximately,
5.degree. C. to about 10.degree. C., less than 10.degree. C., less
than 15.degree. C., etc.). Protection of the overlying cells (e.g.,
typically water-rich dermal and epidermal skin cells) from freeze
damage during dermatological and related aesthetic procedures that
involve sustained exposure to cold temperatures may include
improving the freeze tolerance and/or freeze avoidance of these
skin cells by using, for example, cryoprotectants for inhibiting or
preventing such freeze damage.
C. Treatment Systems
[0108] FIG. 1 shows the treatment system 100 that can include the
applicator 102, the restraint apparatus 107, a connector 104, and a
control module 106 for controlling operation of the applicator 102.
The applicator 102 can conform closely to the contours of the
subject's body. The restraint apparatus 107 can include a head
support assembly 108 for holding the subject's head 109 and
restraints 111a, 111b (collectively "restraints 111") for
connecting the applicator 102 to the head support assembly 108. The
head support assembly 108 can include an adjustable pillow 130 with
independently movable features capable of positioning different
regions of the subject's body any number of times. After completing
a cryotherapy procedure, the restraints 111 can be detached from
the pillow 130 to release the subject 101.
[0109] FIG. 1 shows the head support assembly 108 holding the
subject's head 109 at a preferred position for treating submental
tissue, reducing the likelihood of unintentional movement of the
applicator 102 relative to the treatment site, to enhance a
treatment. In some embodiments, the head support assembly 108 can
include a head adjuster device 113 and a neck adjuster device 115.
The head adjuster device 113 can be operated to adjust the forward
tilt of the subject's head 109, and the neck adjuster device 115
can be operated to adjust the position of the subject's neck. The
restraints 111 can be tensioned to pull the applicator 102 toward
the subject's submental region and hold the subject's shoulders
against side portions 125a, 125b (collectively "side portions
125"). The restraints 111 can be sufficiently tensioned to inhibit
movement of the applicator 102 relative to the treatment site while
the applicator 102 non-invasively cools the treatment site.
[0110] The connector 104 extends from the control module 106 to the
applicator 102. FIG. 2 is a cross-sectional view of the connector
104 taken along line 2-2 of FIG. 1. Referring to FIG. 1, the
connector 104 can provide suction for drawing tissue into the
applicator 102 and energy (e.g., electrical energy) and fluid
(e.g., coolant) from the control module 106 to the applicator 102.
Referring now to FIG. 2, the connector 104 can include a main body
179, a supply fluid line or lumen 180a ("supply fluid line 180a"),
and a return fluid line or lumen 180b ("return fluid line 180b").
The main body 179 may be configured (via one or more adjustable
joints) to "set" in place for the treatment of the subject 101. The
supply and return fluid lines 180a, 180b can be conduits
comprising, in whole or in part, polyethylene, polyvinyl chloride,
polyurethane, and/or other materials that can accommodate
circulating coolant, such as water, glycol, synthetic heat transfer
fluid, oil, a refrigerant, and/or any other suitable heat
conducting fluid. In one embodiment, each fluid line 180a, 180b can
be a flexible hose surrounded by the main body 179. The connector
104 can also include one or more electrical lines 112 for providing
power to the applicator 102 and one or more control lines 116 for
providing communication between the control module 106 (FIG. 1) and
the applicator 102 (FIG. 1). To provide suction, the connector 104
can include one or more vacuum lines 119. In various embodiments,
the connector 104 can include a bundle of fluid conduits, a bundle
of power lines, wired connections, vacuum lines, and other bundled
and/or unbundled components selected to provide ergonomic comfort,
minimize unwanted motion (and thus potential inefficient removal of
heat from the subject 101), and/or to provide an aesthetic
appearance to the treatment system 100.
[0111] Referring again to FIG. 1, the control module 106 can
include a fluid system 105 (illustrated in phantom line), a power
supply 110 (illustrated in phantom line), and a controller 114
carried by a housing 124 with wheels 126. The fluid system 105 can
include a fluid chamber and a refrigeration unit, a cooling tower,
a thermoelectric chiller, heaters, or any other device capable of
controlling the temperature of coolant in the fluid chamber. The
coolant can be continuously or intermittently delivered to the
applicator 102 via the supply fluid line 180a (FIG. 2) and can
circulate through the applicator 102 to absorb heat. The coolant,
which has absorbed heat, can flow from the applicator 102 back to
the control module 106 via the return fluid line 180b (FIG. 2). For
warming periods, the control module 106 can heat the coolant such
that warm coolant is circulated through the applicator 102.
Alternatively, a municipal water supply (e.g., tap water) can be
used in place of or in conjunction with the control module 106.
[0112] A pressurization device 117 can provide suction to the
applicator 102 via the vacuum line 119 (FIG. 2) and can include one
or more pumps, vacuum sources, or the like. Air pressure can be
controlled by a regulator located between the pressurization device
117 and the applicator 102. If the vacuum level is too low, tissue
may not be drawn adequately (or at all) into the applicator 102. If
the vacuum level is too high, undesirable discomfort to the patient
101 and/or tissue damage could occur. The control module 106 can
control the vacuum level to draw tissue into the applicator 102
while maintaining a desired level of comfort. According to certain
embodiments, approximately 0.5 inch Hg, 1 inch Hg, 2 inches Hg, 3
inches Hg, or 5 inches Hg vacuum is applied to draw facial or neck
tissue into the applicator 102. Other vacuum levels can be selected
based on the characteristics of the tissue and desired level of
comfort.
[0113] The power supply 110 can provide a direct current voltage
for powering electrical elements (e.g., thermal devices) of the
applicator 102 via the line 112 (FIG. 2). An operator can use an
input/output device in the form of a screen 118 ("input/output
device 118") of the controller 114 to control operation of the
treatment system 100, and the input/output device 118 can display
the state of operation of the treatment system 100 and/or progress
of a treatment protocol. In some embodiments, the controller 114
can exchange data with the applicator 102 via the line 116 (FIG.
2), a wireless communication link, or an optical communication link
and can monitor and adjust treatment based on, without limitation,
one or more treatment profiles and/or patient-specific treatment
plans, such as those described, for example, in commonly assigned
U.S. Pat. No. 8,275,442. Each treatment profile and treatment plan
can include one or more segments, and each segment can include
temperature profiles, vacuum levels, and/or specified durations
(e.g., 1 minute, 5 minutes, 10 minutes, 20 minutes, 30 minutes, 1
hour, 2 hours, etc.). Additionally, if the treatment system 100
includes multiple applicators, a treatment profile can include
specific profiles for each applicator to concurrently or
sequentially treat multiple treatment sites, including, but not
limited to, sites along the subject's face and/or neck (e.g.,
submental sites, submandibular sites, etc.), abdomen, thighs,
buttocks, knees, back, arms, ankle region, or other treatment
sites. In some embodiments, the controller 114 can be incorporated
into the applicator 102 or another component of the treatment
system 100.
[0114] FIG. 3 is a side view of the applicator 102 applied to the
subject 101 while the pillow 130 (shown in cross section) supports
the subject in accordance with embodiments of the technology. The
pillow 130 can position the subject's body such that the submental
region is at a suitable position for treatment by the applicator
102. An expandable member 121 of the head adjuster device 113 (FIG.
1) can be expanded to tilt (indicated by arrow 122) the subject's
head 109. An expandable member 123 of the neck adjuster device 115
(FIG. 1) can be expanded such that the pillow 130 pushes against
and moves the subject's neck 127 (indicated by arrow 128). The
expandable members 121, 123 can be independently inflated/deflated
any number of times in a treatment session.
D. Applicators
[0115] FIG. 4 is a cross-sectional view of the applicator 102 taken
along line 4-4 of FIG. 3. The applicator 102 can include an
applicator unit 202 and a liner assembly 204. Tissue can be drawn
into a tissue-receiving cavity 230 ("cavity 230") and against a
patient-contact surface 237 of the liner assembly 204. The
applicator unit 202 can extract heat from tissue 211 located in the
tissue-receiving cavity 230. Heat (represented by arrows) from the
tissue 211 can be conductively transferred through the liner
assembly 204 to temperature-controlled heat-exchanging surfaces 239
of the applicator unit 202 such that heat flows across
substantially all of the applicator/skin interface.
[0116] To effectively cool relatively shallow targeted submental
tissue without adversely effecting deeper non-targeted tissue, the
tissue 211 can be drawn against the bottom 233 of the relatively
shallow tissue-receiving cavity 230. Subcutaneous lipid-rich cells
in a subcutaneous layer 213 can be cooled an amount sufficient to
be biologically effective in affecting (e.g., damaging and/or
reducing) such lipid-rich cells without affecting non-target cells
to the same or greater extent. In some procedures, platysma muscle
221, digastric muscle 223, mylohyoid muscle 225, geniohyoid muscle
227, and/or other non-targeted tissues can be generally unaffected
by the treatment. In some procedures, adipose tissue in the
subcutaneous layer 213 can be selectively cooled/heated without
significantly affecting non-targeted tissue. Although the
illustrated applicator 102 is positioned to treat mostly submental
tissue, it can also be positioned to treat tissue at the
submandibular region, neck region, or other target regions. Straps,
harnesses, or other retaining apparatuses can secure the applicator
102 to the subject throughout therapy.
[0117] FIG. 5 is an isometric view of the applicator unit 202 in
accordance with embodiments of the technology. The applicator unit
202 can include a cup assembly 228 for cooling/heating tissue and a
housing 240 for protecting the cup assembly 228. The cup assembly
228 can include a cup 231 and a contoured lip 232. The cup 231 can
be contoured to accommodate tissue pulled into the cavity 230 and
can serve as a heat sink to provide effective cooling/heating of
tissue. The contoured lip 232 can define a mouth 242 of the cavity
230 and can sealingly engage, for example, a liner assembly (e.g.,
liner assembly 204 of FIG. 3), the subject's skin (e.g., if the
contoured lip 232 is placed directly against skin), a
cryoprotectant gel pad, or other surface. The contoured lip 232 can
include two spaced apart arcuate lip portions 290a, 290b and side
lip portions 292a, 292b connecting the lip portions 290a, 290b.
Fasteners 241 (e.g., hook or loop fastener) can be coupled to or
part of the housing 240. Various features of the applicator unit
202 are discussed in detail in connection with FIGS. 6-9.
[0118] FIG. 6 is an exploded isometric view of the applicator unit
202 in accordance with embodiments of the technology. In some
embodiments, including the illustrated embodiment, the housing 240
includes two housing sections 244a, 244b that cooperate to surround
internal components, but the housing 240 can have a wide range of
multi-piece or one-piece constructions selected based on the
configuration of cooling unit 246 and/or the cup assembly 228. The
cooling unit 246 can be in thermal communication with a base 245 of
the cup assembly 228. In a cooling mode, the cooling unit 246 cools
the cup assembly 228, and in a heating mode, the cooling unit 246
heats the cup assembly 228.
[0119] FIG. 7 is a top view of the applicator unit 202 in
accordance with embodiments of the technology. The cup 231 can
include spaced apart sidewalls 260a, 260b, a bottom 270, and end
portions 272a, 272b. The sidewalls 260a, 260b can be curved, flat,
or combinations thereof and can extend between the end portions
272a, 272b. The bottom 270 can extend between the sidewalls 260a,
260b and can extend between the end portions 272a, 272b.
[0120] The cup 231 can be a thermally conductive cup made, in whole
or in part, of a thermally conductive material for rapid cooling
and/or heating to, for example, reduce treatment times and/or
produce generally flat temperature profiles over the
heat-exchanging surface 239 or a portion thereof. Because the
subject's body heat can be rapidly conducted to the cup 231, the
cooled skin can be kept at a generally flat temperature profile
(e.g., .+-.3.degree. C. of a target temperature) even though
regions of the skin, or underlying tissue, may experience different
amounts of blood flow. The thermally conductive materials can
include, without limitation, metal/metal alloys (e.g., stainless
steel, copper alloys, etc.), pure metal (e.g., pure copper), or
other rigid or flexible high heat transfer materials such as
thermally conductive plastics. In some embodiments, the thermally
conductive material at room temperature can have a thermal
conductivity equal to or greater than about 13 W/(mK), 50 W/(mK),
100 W/(mK), 200 W/(mK), 300 W/(mK), 350 W/(mK), and ranges
encompassing such thermal conductivities. In some embodiments, the
cup 231 can have a multi-piece construction with different pieces
made of different materials to provide different amounts of heat
flow at different locations. In other embodiments, the cup 231 has
a unitary construction and is made of a single material, such as
metal. The surface 239 can be a smooth surface that extends
continuously along at least most of the cavity 230. When tissue is
drawn against the surface 239, the skin can be slightly stretched
to reduce the thickness of the skin to increase heat transfer
between target tissue and the surface 239. Thus, the mechanical
properties, thermal properties, shape, and/or dimensions of the cup
231 can be selected based on, for example, target treatment
temperatures and/or desired volume of tissue to be drawn into the
cavity 230.
[0121] One or more vacuum ports 250 can be in fluid communication
with the cavity 230. The number and locations of the vacuum ports
250 can be selected based on, for example, desired tissue draw,
considerations of patient comfort, and the desired vacuum level. If
the vacuum level is too low, tissue will not be drawn adequately
(or at all) into the cavity 230. If the vacuum level is too high,
undesirable discomfort to the patient and/or tissue damage could
occur. The vacuum ports 250 can be positioned near the bottom of
the cavity 230 to comfortably draw the tissue deep into the cavity
230.
[0122] Vacuum ports 280a, 280b, 280c (collectively, "vacuum ports
280") can be positioned along the sidewall 260a, and vacuum ports
291a, 291b, 291c (collectively, "vacuum ports 291") can be
positioned along the sidewall 260b. The vacuum ports 280, 291 can
be used to draw a liner assembly, cryoprotectant gel pad, and/or
tissue against the respective sidewalls 260a, 260b. In other
embodiments, adhesive (e.g., pressure-sensitive adhesive), snaps,
or hook and loop type fasteners can be positioned at various
locations along the surface 239 and can couple a liner assembly to
the applicator unit 202. In yet other embodiments, a cinching
device (not shown) can couple liner assemblies to the applicator
unit 202.
[0123] FIG. 8 is a cross-sectional view of the applicator unit 202
taken along line 8-8 of FIG. 7. FIG. 9 is a cross-sectional view of
the applicator unit 202 taken along line 9-9 of FIG. 7. Referring
now to FIG. 8, cavity 230 can include a first end 300, a second end
302, and a central section 304 extending between the first and
second ends 300, 302. The central section 304 can have a curved
longitudinal axis 310 extending along a substantially circular
path, an elliptical path, or other desired nonlinear or linear
path. In some embodiments, the longitudinal axis 310 has a
curvature generally equal to the curvature of at least one of the
arcuate lip portions 290a, 290b (as viewed from the side). In other
embodiments, the longitudinal axis 310 can have a curvature that is
different than the curvature of one or both lip portions 290a, 290b
and can be selected based on the shape of the subject's body.
[0124] The cavity 230 can have substantially uniform depth along
most of curved longitudinal axis 310. Embodiments of the applicator
unit 202 for treating submental tissue can have a maximum depth 312
equal to or less than about 0.5 cm, 2 cm, 2.5 cm, 3 cm, or 5 cm,
for example. Embodiments of the applicator unit 202 for treating
facial tissue can have a maximum depth 312 equal to or less than
about 0.5 cm, 2 cm, or 3 cm, for example. The maximum depth 312 can
be selected based on, for example, the volume of targeted tissue,
characteristics of the targeted tissue, and/or desired level of
patient comfort.
[0125] FIG. 9 shows the sidewalls 260a, 260b splayed out to
facilitate conformably drawing tissue into the tissue-receiving
cavity 230. The positive draft angle of the sidewalls 260a, 260b
can be increased or decreased to decrease or increase,
respectively, the vacuum level needed to fill the cavity 230 with
tissue. Referring to FIGS. 8 and 9 together, the bottom of the
cavity 230 can define a curved longitudinal profile shape in a
longitudinal direction (e.g., a direction parallel to the axis 310
in FIG. 8), and the bottom of the cavity 230 can define a curved
transverse profile shape in a transverse direction. In one
embodiment, a radius of curvature of the longitudinal curve profile
shape of FIG. 8 can be greater than a radius of curvature of the
transverse curved profile of FIG. 9. The tissue-receiving cavities
disclosed herein can have substantially U-shaped cross sections
(see cavity 230 of FIG. 9), V-shaped cross sections (see
tissue-receiving cavity 230' of FIG. 9A), or partially
circular/elliptical cross-sections (see tissue-receiving cavity
230'' of FIG. 9B), as well as or other cross sections suitable for
receiving tissue.
[0126] FIG. 9 shows the contoured lip 232 connected to an upper
edge 333 of the cup 231. The contoured lip 232 can be made, in
whole or in part, of silicon, rubber, soft plastic, or other
suitable highly compliant materials. The mechanical properties,
thermal properties, shape, and/or dimensions of the contoured lip
232 can be selected based on, for example, whether the contoured
lip 232 contacts a liner assembly, a surface of a cryoprotectant
gel pad, or the subject's skin.
[0127] Sensors 470 can be coupled to the surface 239, embedded in
the cup 231, or located at other suitable positions (e.g., carried
by a film applied to the cup 231). The sensors 470 can be
temperature sensors, such as thermistors, positioned to detect
temperature changes associated with warm tissue being drawn into
the cup 231. A control module (e.g., control module 106 of FIG. 1)
can interpret the detected temperature increase associated with
skin contact and can monitor, for example, the depth of tissue draw
and tissue contact based on the locations and amount of temperature
increase. In some embodiments, the sensors 470 measure heat flux
and/or pressure (e.g., contact pressure) with the skin of the
patient. In yet further embodiments, the sensors 470 can be tissue
impedance sensors or other sensors capable of detecting the
presence and/or characteristics of tissue. Feedback from the
sensors 470 can be collected in real-time and used in concert with
treatment administration to efficaciously target specific tissue.
The sensor measurements can also indicate other changes or
anomalies that can occur during treatment administration. For
example, an increase in temperature detected by the sensors 470 can
indicate either a freezing event at the skin or movement of the
applicator 102. An operator can inspect the subject's skin and/or
applicator 102 in response to a detected increase in temperature.
Methods and systems for collection of feedback data and monitoring
of temperature measurements are described in commonly assigned U.S.
Pat. No. 8,285,390.
[0128] Referring again to FIG. 6, the cooling unit 246 can be
mounted directly to the cup assembly 228 and can include a thermal
device 350 and a connection assembly 353. The thermal device 350
can include, without limitation, one or more thermoelectric
elements (e.g., Peltier-type elements), fluid-cooled elements,
heat-exchanging units, or combinations thereof. In some
embodiments, the thermal device 350 includes thermoelectric
elements 352 for cooling/heating the base 245 and a fluid-cooled
element 354 for cooling/heating the thermoelectric elements 352. In
a cooling mode, the fluid-cooled element 354 can cool the backside
of the thermoelectric elements 352 to keep the thermoelectric
elements 352 at or below a target temperature. In a heating mode,
the fluid-cooled element 354 can heat the backside of the
thermoelectric elements 352 to keep the thermoelectric elements 352
at or above a target temperature. Although the illustrated thermal
device 350 has two thermoelectric elements 352, it can have any
desired number of thermoelectric elements 352 at various locations
about the cup 231. In other embodiments, the thermal device 350 has
only fluid-cooled elements or only non-fluid cooled thermoelectric
elements. The configurations and components of the thermal device
350 can be selected based on the desired power consumption and
targeted temperatures. The connection assembly 353 can include
circuitry, a circuit board, fittings (e.g., inlet ports, outlet
ports, etc.), or the like. The cooling unit 246 can also be
incorporated into part of the cup assembly 228. In such
embodiments, the thermoelectric elements 352 can be embedded or
otherwise disposed in the cup 231 to reduce the distance from the
tissue to the thermoelectric elements 352.
[0129] FIG. 10 is an isometric view of the liner assembly 204 in
accordance with one embodiment. FIG. 11 is a top view of the liner
assembly 204 of FIG. 10. FIG. 12 is a cross-sectional view of the
liner assembly 204 taken along line 12-12 of FIG. 11. When the
liner assembly 204 is positioned on an applicator unit, the liner
assembly 204 can provide a sanitary surface for contacting a
patient and can also effectively transfer heat between the subject
and the applicator unit. After treatment, the liner assembly 204
can be discarded or sanitized and reused.
[0130] The liner assembly 204 can include a cup liner 400 for
overlaying the heat transfer surface of an applicator unit and
attachment members 404a, 404b for securing the liner assembly 204
to the applicator unit. The cup liner 400 can include a lip portion
410 and a main body 420. When the applicator unit is inserted into
the main body 420, the lip portion 410 can surround the mouth of a
tissue receiving cavity and an elongated opening 450 can be aligned
with a trench (see trench 451 of FIG. 8) of the applicator unit,
and openings 460 can be aligned with the vacuum ports of the
applicator unit. In highly compliant embodiments, the liner
assembly 204 can be made, in whole or in part, of rubber, soft
plastic, or other compliant material.
[0131] Liner assemblies can also be a film, a sheet, a sleeve, or
other component suitable for defining an interface surface to
prevent direct contact between the applicator unit and the
subject's skin to reduce the likelihood of cross-contamination
between patients, minimize cleaning requirements, etc. Exemplary
protective liners can be sheets, sleeves, or other components
constructed from latex, rubber, nylon, Kevlar.RTM., or other
substantially impermeable or semi-permeable material. Further
details regarding a patient protection device may be found in U.S.
Patent Publication No. 2008/0077201. A liner or protective sleeve
may be positioned between the absorbent and the applicator to
shield the applicator and to provide a sanitary barrier that is, in
some embodiments, inexpensive and thus disposable.
E. Treatment Methods
[0132] FIGS. 13-17 are a series of views of a method of performing
cryotherapy in accordance with various embodiments of the present
technology. Generally, targeted tissue can be drawn into the
applicator 102 until the tissue is in thermal contact a region of
the cup assembly 228 located at a bottom of the cavity 230. The cup
assembly 228 can be cooled to extract heat from the tissue so as to
cool/heat targeted tissue an amount sufficient to be biologically
effective in damaging and/or reducing targeted cells. FIG. 17 shows
a pretreatment tissue profile of a double chin in phantom line and
the post treatment tissue profile in solid line. Various details of
operation are discussed in detail below.
[0133] FIG. 13 shows the applicator 102 ready to be placed at a
treatment site 502. In procedures for reducing a double chin, the
applicator 102 can be aligned with and placed generally at the
submental region (i.e., the submental triangle). Although the
subject's head is shown at a generally horizontal orientation, the
subject's head can be held at other orientations. For example, a
pillow (e.g., pillow 130 of FIG. 1) or other support device can be
used to elevate, tilt, or otherwise position the subject's head,
neck, shoulders, and/or other body parts. The applicator 102 can be
placed against the subject such that it extends laterally across
the submental triangle or a portion thereof. It will be appreciated
that the applicator 102 can be placed at other locations along the
patient's body and the orientation of the applicator 102 can be
selected to facilitate a relatively close fit.
[0134] FIG. 14 shows the applicator 102 placed against the
subject's skin. FIG. 15 is a cross-sectional view of the applicator
102 contacting the subject's skin 500 before drawing tissue. FIG.
16 is a cross-sectional view of the applicator 102 after tissue has
been drawn into the cavity 230. Although not shown in FIGS. 13-16
for ease of illustration, other elements, materials, components
(e.g., gel pads, absorbents, etc.) can be located between the skin
500 and the applicator 102. U.S. Pub. No. 2007/0255362 and U.S.
Patent Publication No. 2008/0077201 and U.S. application Ser. No.
14/610,807 disclose components, materials (e.g., coupling gels,
cryoprotectants, compositions, etc.), and elements (e.g., coupling
devices, liners/protective sleeves, absorbents, etc.) that can be
placed between the skin 500 and the applicator 102.
[0135] Referring to FIGS. 15 and 16, when a vacuum is applied, the
skin 500 can be moved (indicated by arrows in FIG. 15) towards the
bottom of the cavity 230. The vacuum level can be selected to
comfortably pull the tissue into contact with the desired area of
the applicator 102, and the skin 500 and underlying tissue can be
pulled away from the subject's body which can assist in cooling
underlying tissue by, e.g., lengthening the distance between
targeted subcutaneous fat and the muscle tissue. After a sufficient
amount of tissue fills most or all of the cavity 230, the tissue is
cooled/heated. FIG. 16 shows mostly submental tissue located in the
cavity 230. For example, substantially all the tissue 514 can be
submental tissue to alter only the submental region. In other
procedures, tissue at the submandibular region can be drawn into
the cavity 230 to reduce, for example, jowl fat.
[0136] Because a target volume of fat may be relatively small and
localized, the applicator 102 can provide well-defined margins of
the treatment area. In some embodiments, the applicator 102 can
conductively cool an area equal to or less than about 20 cm.sup.2,
30 cm.sup.2, or 40 cm.sup.2 to avoid damaging non-targeted tissue
(e.g., tissue adjacent to the submental region). In some
embodiments, the patient-contact surface 237 can have a surface
area equal to or less than about 20 cm.sup.2, 30 cm.sup.2, or 40
cm.sup.2. An operator can have an array of applicators with
different dimensions so that the operator can select an applicator
to match a patient's anatomy.
[0137] The control module 106 (FIG. 1) can automatically begin
heating/cooling the tissue. In other embodiments, the control
module 106 (FIG. 1) can notify the operator that the applicator 102
is ready for treatment. The operator can inspect the applicator 102
and can begin treatment using the control module 106. Heat
(represented by arrows in FIG. 16) can be transferred from targeted
tissue to the thermoelectric elements 352. Coolant can flow through
an inlet port 550 connected to the fluid line 180a. The coolant can
circulate through passages 552 to absorb heat from the
thermoelectric elements 352 and can exit the passages 552 via the
outlet port 560 connected to the fluid line 180b. The heated
coolant can flow back to the control module 106 (FIG. 1) for
cooling.
[0138] In contrast to invasive procedures in which coolant is
injected directly into targeted tissue, each of the sidewalls 260a,
260b and bottom 270 (FIG. 7) can conductively cool tissue to
produce a desired temperature in target tissue without bruising,
pain, or other problems caused by injections and perfusion of
injected fluid. For example, perfusion of injected fluid can affect
the thermal characteristics of the treatment site and result in
undesired temperature profiles. As such, the non-invasive
conductive cooling provided by the applicator 102 can be more
accurate than invasive procedures that rely on injecting fluids.
The illustrated targeted tissue of FIG. 16 can be cooled to a
temperature range from about -20.degree. C. to about 10.degree. C.,
from about 0.degree. C. to about 20.degree. C., from about
-15.degree. C. to about 5.degree. C., from about -5.degree. C. to
about 15.degree. C., or from about -10.degree. C. to about
0.degree. C. In one embodiment, the patient-contact surface 237 can
be kept at a temperature less than about 5.degree. C. to extract
heat from subcutaneous lipid-rich cells such that those cells are
selectively reduced or damaged. Because non-lipid-rich cells
usually can withstand colder temperatures better than lipid-rich
cells, the subcutaneous lipid-rich cells can be injured selectively
while maintaining the non-lipid-rich cells (e.g., non-lipid-rich
cells in the dermis and epidermis).
[0139] Lines 119 of FIG. 16 can provide sufficient vacuum to hold
the skin 500 against the patient-contact surface 237. The tissue
514 can fill substantially the entire cavity 230. For example, the
tissue 514 can occupy at least 70%, 80%, 90%, or 90% of the volume
of the cavity 230 to avoid or minimize air pockets that may impair
heat transfer. The restraint apparatus 107 of FIG. 1 can be
adjusted such that the applicator 102 applies sufficient pressure
to reduce, limit, or eliminate blood flow to deeper tissue to
improve cooling efficiency because blood circulation is one
mechanism for maintaining a constant body temperature of about
37.degree. C. Blood flow through the dermis and subcutaneous layer
of the tissue is a heat source that counteracts the cooling of the
targeted tissue (e.g., sub-dermal fat). If the blood flow is not
reduced, cooling the subcutaneous tissues would require not only
removing the specific heat of the tissues but also that of the
blood circulating through the tissues. Thus, reducing or
eliminating blood flow through the tissue 514 can improve the
efficiency of cooling and avoid excessive heat loss from the dermis
and epidermis.
[0140] It will be appreciated that while a region of the body has
been cooled or heated to the target temperature, in actuality that
region of the body may be close but not equal to the target
temperature, e.g., because of the body's natural heating and
cooling variations. Thus, although the applicator 102 may attempt
to heat or cool the target tissue to the target temperature or to
provide a target heat flux, the sensors 470 (FIG. 9) may measure a
sufficiently close temperature or heat flux. If the target
temperature or heat flux has not been reached, operation of the
cooling unit can be adjusted to change the heat flux to maintain
the target temperature or "set-point" selectively to affect
targeted tissue. When the prescribed segment duration expires, the
next treatment profile segment can be performed.
[0141] FIG. 17 shows subject after completing cryotherapy with the
pretreatment tissue profile of a double chin (shown in phantom
line) and the post treatment tissue profile without the double chin
(shown in solid line). It may take a few days to a few weeks, or
longer, for the adipocytes to break down and be absorbed. A
significant decrease in fat thickness may occur gradually over 1-3
months following treatment. Additional treatments can be performed
until a desired result is achieved. For example, one or more
treatments can be performed to substantially reduce (e.g., visibly
reduce) or eliminate a double chin.
[0142] The treatment procedure of FIGS. 13-17 can also involve use
of cryoprotectant between the applicator 102 and the skin. The
cryoprotectant can be a freezing point temperature depressant that
may additionally include a thickening agent, a pH buffer, a
humectant, a surfactant, and/or other additives. The temperature
depressant may include, for example, polypropylene glycol (PPG),
polyethylene glycol (PEG), dimethyl sulfoxide (DMSO), or other
suitable alcohol compounds. In a particular embodiment, a
cryoprotectant may include about 30% polypropylene glycol, about
30% glycerin (a humectant), and about 40% ethanol. In another
embodiment, a cryoprotectant may include about 40% propylene
glycol, about 0.8% hydroxyethylcellulose (a thickening agent), and
about 59.2% water. In a further embodiment, a cryoprotectant may
include about 50% polypropylene glycol, about 40% glycerin, and
about 10% ethanol. Other cryoprotectants or agents can also be used
and can be carried by a cotton pad or other element. U.S.
application Ser. No. 14/610,807 is incorporated by reference in its
entirety and discloses various compositions that can be used as
cryoprotectants.
F. Applicator Units
[0143] FIGS. 18-22 are isometric views of applicators in accordance
with embodiments of the present technology. The description of the
applicator 102 (FIGS. 1-17) applies equally to the applicators of
FIGS. 18-21 unless indicated otherwise. FIG. 18 shows an applicator
600 that includes a cup 601 defining a tissue-receiving cavity 610.
The cup 601 has sidewalls 602, end portions 603, and a bottom 604.
A thermally conductive edge 616 (e.g., a rounded edge or a blunt
edge) can be made of metal or other thermally conductive material
capable of cooling/heating margins of the treatment site. An array
of vacuum ports 612 (one labeled in FIG. 18) are in fluid
communication with the tissue-receiving cavity 610. A base 624 can
be in thermal communication with the cup 601 and can include,
without limitation, one or more thermal elements, controllers, or
the like.
[0144] FIG. 19 shows an applicator 630 that includes a cup 631 and
a base 656. The cup 631 has sidewalls 632, end portions 633, and a
bottom 634 and defines a tissue-receiving cavity 640. A lip portion
642 is coupled to the cup 631 and flares outwardly. The cavity 640
(as viewed from above) can have an elongate shape (e.g., generally
elliptical shape, rounded rectangle shape, etc.), a circular shape,
or other suitable shape for receiving tissue. A vacuum port 652 is
in fluid communication with the tissue-receiving cavity 640.
[0145] FIG. 20 shows an applicator 660 that includes a cup 661 with
sidewalls 662, end portions 663, and a bottom 664 and can define a
tissue-receiving cavity 670. A lip portion 672 can be a bladder
seal or other sealing member. A vacuum port 675 can provide a
vacuum for drawing the submental tissue into the cup 661, and
vacuum ports 677 can provide a vacuum for drawing a liner assembly
or skin against the cup 661. FIG. 21 shows the applicator 660 with
a base 680 that serves as a heat spreader to increase heat
flows.
[0146] Exemplary components and features that can be incorporated
into the applicators disclosed herein are described in, e.g.,
commonly assigned U.S. Pat. No. 7,854,754 and U.S. Patent
Publication Nos. 2008/0077201, 2008/0077211, 2008/0287839,
2011/0238050 and 2011/0238051. The patient protection devices
(e.g., liners or liner assemblies) may also include or incorporate
various storage, computing, and communications devices, such as a
radio frequency identification (RFID) component, allowing for
example, use to be monitored and/or metered. Additionally,
restraint apparatuses or components disclosed herein can be used to
perform the method discussed in connection with FIGS. 13-16. For
example, the restraint apparatus 107 can be used to hold the
applicators disclosed herein to perform the cryotherapy of FIGS.
13-16.
[0147] FIG. 22 is an isometric view of an applicator 682 in
accordance with embodiments of the technology. The applicator 682
is generally similar to the applicator 102 discussed in connection
with FIGS. 1-17. The applicator 682 of FIG. 22 includes a housing
684 with coupling features in the form of loops 692 configured to
receive restraints, such as flexible straps, belts, etc.
[0148] FIG. 23A is an isometric view of an applicator 695 suitable
for use with treatment systems disclosed herein. The applicator 695
can be generally similar to the applicators discussed in connection
with FIGS. 1-23. The applicator 695 is connected to a connector 104
via a flexible joint 696. FIG. 23B shows the flexible joint 696
extending from a side of the applicator 695 or from any other
suitable location along the applicator 695.
[0149] FIG. 23C is an exploded isometric view of the applicator 695
in accordance with embodiments of the technology, and FIG. 23D is a
cross-sectional view of the applicator of FIG. 23A. Referring to
these figures, a housing 693 of the applicator 695 can include
multiple housing sections 697 that cooperate to surround and
protect internal components, such as a cooling unit 694. The
cooling unit 694 can heat or cool a conductive cup 698. A manifold
system 699 can include lines 701 in fluid communication with ports
703 (one identified in FIG. 23C) of the cup 698. The manifold
system 699 can also include coolant lines 705 (FIG. 23D) that
provide coolant to and take away coolant from the cooling unit 694.
The applicator 695 can have other components, including liner
assemblies, sensors, manifolds, vibrators, massage devices, or
combinations thereof. Additionally, the manifold system 699 can
include vacuum lines 687 that can be fluid communication with
vacuum ports 688 (two identified in FIG. 23C) of the cup 698. The
vacuum lines 687 can be used to draw a vacuum to hold a liner
assembly against the conductive cup 698.
[0150] Although noninvasive applicators are illustrated and
discussed with respect to FIGS. 1-23D, minimally invasive
applicators may also be employed. As an example, a cryoprobe, an
electrode, an injector (e.g., a needle), and/or other invasive
component may be incorporated into the applicators disclosed herein
and can be inserted directly into the targeted tissue (e.g.,
subcutaneous adipose tissue) to cool, freeze, or otherwise
thermally process targeted tissue. Treatment systems and
applicators disclosed herein can also include elements (e.g.,
electrodes, vibrators, etc.) for delivering energy, such as
radiofrequency energy, ultrasound energy (e.g., low frequency
ultrasound, high frequency ultrasound, etc.), mechanical massage,
and/or electric fields. The energy can be selected to affect
treatment by, for example, heating tissue. Additionally or
alternatively, energy can be used to affect the crystal formation
in non-targeted tissues while allowing cooling of the targeted
tissue. In non-targeted cells or structures, non-thermal energy
parameters may be selected to reduce ice crystal size and/or
length, reduce freezing lethality, or the like. In targeted cells
or structures, non-thermal energy parameters may be selected to
enhance crystal nucleation. Thus, energy can be selectively applied
to control therapy. The treatment systems disclosed herein may be
used with a substance that may provide a thermal coupling between
the subject's skin and the thermal element(s) to improve heat
transfer therebetween. The substance may be a fluid, e.g., a
liquid, a gel, or a paste, which may be hygroscopic, thermally
conductive, and biocompatible.
G. Restraint Systems
[0151] FIG. 24 is an isometric view of the head support assembly
108 in accordance with embodiments of the present technology. The
pillow 130 can include a deployable head cradle portion 702, a neck
support portion 704, and a shoulder support portion 736. The head
cradle portion 702 can include the vertical side portions 125a,
125b and a central region 721 therebetween. The side portions 125a,
125b are positioned to contact opposite sides of a subject's head
located in a concave head-receiving region 711. Movement of the
head cradle portion 702 and the neck support portion 704 for
positioning the patient's body is discussed in connection with
FIGS. 25 and 26.
[0152] The head adjuster device 113 can include a pressurization
device in the form of a pump 724 and a conduit 722. The conduit 722
fluidically couples the pump 724 to an expandable member (not
shown) positioned within the pillow 130. For example, the
expandable member can be positioned between the head cradle portion
702 and the base 709. The pump 724 can be manually pumped to move
the head cradle portion 702 to achieve desired tilt of the
subject's head. The neck adjuster device 115 includes a
pressurization device in the form of a pump 734 and a conduit 732.
The conduit 732 can extend through the side portion 125b and to an
expandable member located generally underneath the neck support
portion 704. The pump 734 can be manually pumped to move the neck
support portion 704 to achieve desired neck tilt of the subject. In
various embodiments, the adjuster devices disclosed herein can
include, without limitation, one or more motorized pumps, valves,
pressure regulators, pneumatic drive devices, mechanical drive
devices, or other suitable components.
[0153] FIG. 25 is a cross-sectional view of the pillow 130 taken
along line 25-25 of FIG. 27 when the pillow 130 is in an undeployed
lowered configuration. FIG. 26 is a cross-sectional view of the
pillow 130 taken along line 26-26 of FIG. 27 when the pillow 130 is
in a deployed raised configuration. Referring now to FIG. 25, the
pillow 130 includes an expandable opening 744 positioned generally
under a region of a head-support surface 742 of the head cradle
portion 702. A deployable member 121 can be positioned in the
expandable opening 744 and can be deployed (e.g., expanded,
inflated, etc.) to move the head cradle portion 702. A flexible
region or joint 743 can connect the head cradle portion 702 to the
base 709. In some embodiments, the head cradle portion 702 can be
rotated an angle ? when the expandable member 121 moves from an
unexpanded configuration (FIG. 25) to an expanded configuration
(FIG. 26). The angle ? can be greater than or equal to about 5
degrees, about 10 degrees, about 20 degrees, about 30 degrees,
about 40 degrees, about 50 degrees, or about 60 degrees to rotate
the support surface 742 a corresponding angle. The amount of
movement of the head cradle portion 702 can be selected based on
the desired amount of head tilt.
[0154] FIG. 25 shows the neck support portion 704 positioned
generally between the head cradle portion 702 and the shoulder
support region 736. When the subject's head is supported by the
head cradle portion 702, the neck support portion 704 is located
under the subject's neck. A flexible portion or joint 747 can
connect the neck support portion 704 to the base 709. An expandable
opening 754 is located under the neck support portion 704. In some
embodiments, an expandable member 123 can be inflated to push the
neck support portion 704 upwardly to define an angle ? that is
greater than or equal to about 5 degrees, about 10 degrees, about
15 degrees, about 20 degrees, about 25 degrees, about 30 degrees,
about 35 degrees, about 40 degrees, or about 45 degrees to rotate
the neck support portion 704 a corresponding angle. The amount of
movement of the neck support portion 704 can be selected based on
the desired support for the subject's neck.
[0155] The pillow 130 can include other types of movable features,
such as movable panels (e.g., rotatable panels, linearly movable
panels, etc.) or other features capable of being moved (e.g.,
translated, rotated, or both) to support, move, and/or otherwise
interact with the subject's body. By way of example, the side
portions 125 (FIG. 24) can include surfaces or features that move
inward firmly to hold the patient's head. The number, locations,
and properties (e.g., cushioning properties, breathability, etc.)
of the movable features can be selected based on, for example,
desired patient comfort, body positioning, and/or treatment
parameters.
[0156] FIG. 27 is a top view of the pillow 130. The neck support
portion 704 extends between shoulder-engagement ends 748a, 748b of
the side portions 125a, 125b, respectively. The shoulder support
region 736 is positioned to support the subject's shoulders when
the shoulder-engagement ends 748a, 748b bear against the subject's
right and left shoulders, respectively. The side portions 125a,
125b can include fasteners or other components for coupling to
restraints (e.g., restraints 111a, 111b of FIG. 1). In some
embodiments, the side portions 125a, 125b include hook or loop
fasteners 763 (illustrated in dash-dot lines) for coupling to loop
or hook fasteners of the restraints 111. For example, the fastener
763 can be sections of hook Velcro.RTM. closure. In other
embodiments, the fastener 763 can include, without limitation, one
or more snaps, buttons, ties, or other attachment features. Other
regions of the pillow 130 can be made of breathable material and
can have one-way or two-way stretchability.
[0157] FIG. 28 is a front view of the pillow 130 with the head
cradle portion 702 having a substantially U-shaped profile
(including V-shaped). The head cradle portion 702 can also have a
semi-circular shape profile or other suitable shape for
accommodating the subject's head. The heights of the side portions
125a, 125b can be selected such that the side portions 125a, 125b
extend upwardly along opposite sides of the subject's head
sufficient distances to reduce or limit side-to-side rotation of
the subject's head.
[0158] FIG. 29 is a side view of the pillow 130. The expandable
opening 744 can be a slot or a slit extending inwardly and
generally parallel to a bottom surface 745 of the pillow 130. An
access feature 760 in the form of a through-hole extends from an
exterior surface 766 of the side portion 125a to the expandable
opening 754 (FIGS. 25 and 26). The bottom surface 745 can comprise
non-skid material for inhibiting movement of the pillow 130 along a
support surface.
[0159] The pillow 130 can be made, in whole or in part, of a
compressible material, including without limitation open-cell foam,
closed-cell foam, or other compliant material. In some embodiments,
the pillow 130 can be made of open-cell polyurethane foam. In some
embodiments, the pillow 130 can include a cover for surrounding the
foam main body. The cover can be removed and washed to provide a
clean surface, and the cover can include fasteners (e.g., loop
fastener, snaps, etc.) for coupling to restraints or other
components.
[0160] FIG. 30 is a top view of the head adjuster device 113. The
pump 724 can be a bulb pump, a squeeze pump, or other manual pump
and may include a button for releasing air. In other embodiments,
the pump 724 is a motorized pump. The conduit 722 can be flexible
tubing that fluidically couples the pump 724 to the expandable
member 121. The expandable member 121 can comprise, in whole or in
part, urethane, silicon, rubber, or other suitable material.
Referring now to FIG. 27, the expandable member 121 (shown in
phantom line) can be an inflatable bladder that extends across most
of the width of the pillow 130.
[0161] FIG. 31 is a top view of the neck adjuster device 115
generally similar to the head adjuster device 113 of FIG. 30 except
as detailed below. The expandable member 123 can comprise urethane,
silicon, rubber, or other suitable material and can be dimensioned
to be located under the neck support portion 704. Referring now to
FIG. 27, the expandable member 123 (shown in phantom line) is
located generally between the side portions 125.
[0162] FIGS. 32-34 are a series of views of a method of performing
cryotherapy using the restraint apparatus 107 in accordance with
various embodiments of the present technology. Generally, the
subject's head 109 can be positioned in the head cradle portion
702. An applicator 787 can then be aligned with the treatment site.
The restraints 111a, 111b can be coupled to the side portions 125a,
125b and tensioned to pull the applicator 787 against the subject's
submental region. After completing the treatment session, the
restraints 111a, 111b can be detached from the respective side
portions 125a, 125b to release the subject. Various details of
operation are discussed in detail below.
[0163] FIG. 32 is a top view of the pillow 130 supporting the
subject's head and restraints 111a, 111b ready to be coupled to the
pillow. The restraints 111a, 111b can be straps permanently or
detachably coupled to an applicator 787. For example, ends 770a,
770b of the respective restraints 111a, 111b can include hook or
loop fasteners, snaps, ties, and/or other features for coupling to
the applicator 787. In other embodiments, the restraints 111a, 111b
can be part of a harness system with a harness body holding the
applicator 787. The number, lengths, and configurations of the
restraints 111a, 111b can be selected based on the location of the
treatment site, desired force for holding the applicator 787, or
other treatment parameters.
[0164] FIG. 33 is a top view of the restraint apparatus 107 holding
the applicator 787 in thermal contact with the subject after
fasteners 780a, 780b (illustrated in phantom line) of the
restraints 111a, 111b have been applied to the pillow 130. The
fasteners 780a, 780b can be loop fasteners located at or proximate
to respective restraint ends 782a, 782b. Tensioning of the
restraints 111, illustrated in a V arrangement, can be adjusted to
inhibit or limit side-to-side movement of the applicator 787 and to
stabilize the applicator 787 even if the subject's head moves
slightly. During a single treatment session, the ends 782a, 782b
can be coupled at various locations along the pillow 130 at
different times, thus providing treatment flexibility.
[0165] FIG. 34 is a left side view of the restraint apparatus 107
holding the applicator 787 in thermal contact with the subject.
Referring to FIGS. 33 and 34, the restraint ends 770a, 770b can be
permanently or detachably coupled to the applicator 787. For
example, the restraint end 770a can include a fastener 787a (e.g.,
a loop fastener shown in phantom line in FIG. 34) coupled to hook
fastener of the applicator 787. The restraint ends 770 can be
repositioned any number of times along the applicator 787. In other
embodiments, the restraint ends 770 can be integrated into or part
of the applicator 787, which can be similar or identical to the any
of the applicators disclosed herein. The connection between the
restraints 111 and the applicator 787 can be selected based on the
design of the applicator.
H. Computing Environments
[0166] FIG. 35 is a schematic block diagram illustrating
subcomponents of a controller in accordance with an embodiment of
the disclosure. The controller can be part of the control module
106 (FIG. 1). For example, the controller 790 can be the controller
114 of FIG. 1 or can be incorporated into the applicators or other
components disclosed herein. The controller 790 can include a
computing device 800 having a processor 801, a memory 802,
input/output devices 803, and/or subsystems and other components
804. The computing device 800 can perform any of a wide variety of
computing processing, storage, sensing, imaging, and/or other
functions. Components of the computing device 800 may be housed in
a single unit or distributed over multiple, interconnected units
(e.g., though a communications network). The components of the
computing device 800 can accordingly include local and/or remote
memory storage devices and any of a wide variety of
computer-readable media.
[0167] As illustrated in FIG. 35, the processor 801 can include a
plurality of functional modules 806, such as software modules, for
execution by the processor 801. The various implementations of
source code (i.e., in a conventional programming language) can be
stored on a computer-readable storage medium or can be embodied on
a transmission medium in a carrier wave. The modules 806 of the
processor can include an input module 808, a database module 810, a
process module 812, an output module 814, and, optionally, a
display module 816.
[0168] In operation, the input module 808 accepts an operator input
819 via the one or more input devices, and communicates the
accepted information or selections to other components for further
processing. The database module 810 organizes records, including
patient records, treatment data sets, treatment profiles and
operating records and other operator activities, and facilitates
storing and retrieving of these records to and from a data storage
device (e.g., internal memory 802, an external database, etc.). Any
type of database organization can be utilized, including a flat
file system, hierarchical database, relational database,
distributed database, etc.
[0169] In the illustrated example, the process module 812 can
generate control variables based on sensor readings 818 from
sensors and/or other data sources, and the output module 814 can
communicate operator input to external computing devices and
control variables to the controller. The display module 816 can be
configured to convert and transmit processing parameters, sensor
readings 818, output signals 820, input data, treatment profiles
and prescribed operational parameters through one or more connected
display devices, such as a display screen 118 (FIG. 1), printer,
speaker system, etc.
[0170] In various embodiments, the processor 801 can be a standard
central processing unit or a secure processor. Secure processors
can be special-purpose processors (e.g., reduced instruction set
processor) that can withstand sophisticated attacks that attempt to
extract data or programming logic. The secure processors may not
have debugging pins that enable an external debugger to monitor the
secure processor's execution or registers. In other embodiments,
the system may employ a secure field programmable gate array, a
smartcard, or other secure devices.
[0171] The memory 802 can be standard memory, secure memory, or a
combination of both memory types. By employing a secure processor
and/or secure memory, the system can ensure that data and
instructions are both highly secure and sensitive operations such
as decryption are shielded from observation. In various
embodiments, the memory 802 can be flash memory, secure serial
EEPROM, secure field programmable gate array, or secure
application-specific integrated circuit. The memory 802 can store
instructions for causing the applicators to cool/heat tissue,
pressurization devices to draw a vacuum, or other acts disclosed
herein. In one embodiment, the memory 802 stores instructions
executable by the controller 790 for the thermal device to
sufficiently cool conductive cups disclosed herein such that
submental vacuum applicators non-invasively cool the subcutaneous
lipid-rich cells to a desired temperature, such as a temperature
less than about 0.degree. C.
[0172] The input/output device 118 can include, without limitation,
a touchscreen, a keyboard, a mouse, a stylus, a push button, a
switch, a potentiometer, a scanner, an audio component such as a
microphone, or any other device suitable for accepting user input
and can also include one or more video monitor, a medium reader, an
audio device such as a speaker, any combination thereof, and any
other device or devices suitable for providing user feedback. For
example, if an applicator moves an undesirable amount during a
treatment session, the input/output device 803 can alert the
subject and/or operator via an audible alarm. The input/output
device 118 can be a touch screen that functions as both an input
device and an output device. The control panel can include visual
indicator devices or controls (e.g., indicator lights, numerical
displays, etc.) and/or audio indicator devices or controls. The
control panel may be a component separate from the input/output
device 118 and/or output device 120, may be integrated applicators,
may be partially integrated with one or more of the devices, may be
in another location, and so on. In alternative embodiments, the
controller 114 can be contained in, attached to, or integrated with
the applicators. Further details with respect to components and/or
operation of applicators, control modules (e.g., treatment units),
and other components may be found in commonly-assigned U.S. Patent
Publication No. 2008/0287839.
[0173] The controller 790 can include any processor, Programmable
Logic Controller, Distributed Control System, secure processor, and
the like. A secure processor can be implemented as an integrated
circuit with access-controlled physical interfaces; tamper
resistant containment; means of detecting and responding to
physical tampering; secure storage; and shielded execution of
computer-executable instructions. Some secure processors also
provide cryptographic accelerator circuitry. Suitable computing
environments and other computing devices and user interfaces are
described in commonly assigned U.S. Pat. No. 8,275,442, entitled
"TREATMENT PLANNING SYSTEMS AND METHODS FOR BODY CONTOURING
APPLICATIONS," which is incorporated herein in its entirety by
reference.
I. Conclusion
[0174] Various embodiments of the technology are described above.
It will be appreciated that details set forth above are provided to
describe the embodiments in a manner sufficient to enable a person
skilled in the relevant art to make and use the disclosed
embodiments. Several of the details and advantages, however, may
not be necessary to practice some embodiments. Additionally, some
well-known structures or functions may not be shown or described in
detail, so as to avoid unnecessarily obscuring the relevant
description of the various embodiments. Although some embodiments
may be within the scope of the technology, they may not be
described in detail with respect to the Figures. Furthermore,
features, structures, or characteristics of various embodiments may
be combined in any suitable manner. Moreover, one skilled in the
art will recognize that there are a number of other technologies
that could be used to perform functions similar to those described
above. While processes or acts are presented in a given order,
alternative embodiments may perform the processes or acts in a
different order, and some processes or acts may be modified,
deleted, and/or moved. The headings provided herein are for
convenience only and do not interpret the scope or meaning of the
described technology.
[0175] Unless the context clearly requires otherwise, throughout
the description, the words "comprise," "comprising," and the like
are to be construed in an inclusive sense as opposed to an
exclusive or exhaustive sense; that is to say, in a sense of
"including, but not limited to." Words using the singular or plural
number also include the plural or singular number, respectively.
Use of the word "or" in reference to a list of two or more items
covers all of the following interpretations of the word: any of the
items in the list, all of the items in the list, and any
combination of the items in the list. Furthermore, the phrase "at
least one of A, B, and C, etc." is intended in the sense one having
skill in the art would understand the convention (e.g., "a system
having at least one of A, B, and C" would include but not be
limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). In those instances where a convention analogous to
"at least one of A, B, or C, etc." is used, in general such a
construction is intended in the sense one having skill in the art
would understand the convention (e.g., "a system having at least
one of A, B, or C" would include but not be limited to systems that
have A alone, B alone, C alone, A and B together, A and C together,
B and C together, and/or A, B, and C together, etc.).
[0176] Any patents, applications and other references, including
any that may be listed in accompanying filing papers, are
incorporated herein by reference. Aspects of the described
technology can be modified, if necessary, to employ the systems,
functions, and concepts of the various references described above
to provide yet further embodiments. These and other changes can be
made in light of the above Detailed Description. While the above
description details certain embodiments and describes the best mode
contemplated, no matter how detailed, various changes can be made.
Implementation details may vary considerably, while still being
encompassed by the technology disclosed herein. As noted above,
particular terminology used when describing certain features or
aspects of the technology should not be taken to imply that the
terminology is being redefined herein to be restricted to any
specific characteristics, features, or aspects of the technology
with which that terminology is associated.
* * * * *